Bausch & Lomb Recalls Cyclopentolate Eye Drops Due to Labeling Errors
Bausch & Lomb recalls specific lots of Cyclopentolate Hydrochloride Ophthalmic Solution because package inserts are missing required updates.
Use caution until it’s fixed
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Contact the company
What happened, in plain English
Bausch & Lomb, Inc. is recalling Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% in both 2 mL and 15 mL bottles. The recall is necessary because the package insert included with the product lacks updates compared to the reference drug insert. This means users may not have the most current information regarding how to use the medication safely. Read more at govinfonow.com/recall/43217-bausch-lomb-recalls-cyclopentolate-eye-drops-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/43217-bausch-lomb-recalls-cyclopentolate-eye-drops-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0645-2016
Cite this page
“Bausch & Lomb Recalls Cyclopentolate Eye Drops Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43217-bausch-lomb-recalls-cyclopentolate-eye-drops-due-to-labeling-errors. Based on FDA recall #D-0645-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0645-2016%22&limit=1).
Why it’s dangerous
The hazard is a labeling issue where the package insert is missing updates compared to the reference drug insert. While the product itself is not described as contaminated or physically defective, the lack of current information could lead to improper use or misunderstanding of safety instructions.
Who’s affected
Patients who have been prescribed Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% by a healthcare provider. The risk applies to anyone using the specific lots listed in the record that contain outdated labeling information.
How to tell if you have this one
Check your eye drop bottles for the brand Bausch & Lomb and the NDC numbers 24208-735-01 (for 2 mL bottles) or 24208-735-05 (for 15 mL bottles). Verify if the lot number matches one of the recalled lots, such as 199691, 221481, or 246552, and check that the expiry date is between January 2016 and June 2017.
- Brand
Bausch & Lomb- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S. Nationwide including Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0645-2016 | Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.; a) Lot #: 199691, Expiry: 02/2016; Lot # 221481, Expiry: 03/2016, Lot #: 223921, Expiry: 05/2016; Lot #: 226211, Expiry: 06/2016; Lot #: 228611, Expiry: 08/2016; Lot #: 230711, Expiry: 09/2016; Lot #: 232591, Expiry: 11/2016; Lot #: 234551, Expiry: 12/2016; Lot #: 238871, Expiry: 01/2017; Lot #: 239801, Expiry: 02/2017; Lot #: 240951, Expiry: 02/2017; Lot #: 242801, Expiry: 04/2017; Lot #: 246551, Expiry: 06/2017. b) Lot #: 199011, Expiry: 01/2016; Lot #: 199692, Expiry: 02/2016; Lot #: 221482, Expiry: 03/2016; Lot #: 222601, Expiry: 04/2016; Lot #: 223922, Expiry: 05/2016; Lot #: 226212, Expiry: 06/2016; Lot #: 228612, Expiry: 08/2016; Lot #: 230712, Expiry: 09/2016; Lot #: 232592, Expiry: 11/2016; Lot #: 234552, Expiry: 12/2016; Lot #: 238872, Expiry: 01/2017; Lot #: 239802, Expiry: 02/2017; Lot #: 240952, Expiry: 02/2017; Lot #: 242802, Expiry: 04/2017; Lot #: 246552, Expiry: 06/2017. | a) 905,956 Bottles, b) 191,375 Bottles | 24208-735-01, 24208-735-06, 24208-735-05 |
| D-0646-2016 | Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.; Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017. | 119,393 Bottles | 24208-590-64, 24208-585-59, 24208-585-64 |
| D-0647-2016 | Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.; a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #: 199961, Expiry: 02/2016; Lot #: 220111, Expiry: 02/2016; Lot #: 222281, Expiry: 04/2016; Lot #: 222291, Expiry: 04/2016; Lot #: 224841, Expiry: 06/2016; Lot #: 228281, Expiry: 07/2016; Lot #: 228291, Expiry: 07/2016; Lot #: 231531, 10/2016; Lot #: 232671, Expiry: 11/2016; Lot #: 232681, Expiry: 11/2016; Lot #: 238931, 01/2017; Lot #: 238941, Expiry: 01/2017; Lot #: 240331, Expiry: 02/2017; Lot #: 242341, Expiry: 04/2017; Lot #: 242351, Expiry: 04/2017; Lot #: 243391, Expiry: 05/2017; Lot #: 246171, Expiry: 06/2017; Lot #: 246341, Expiry: 07/2017. | a) 416,441 Bottles b) 674,177 Bottles | 24208-590-64, 24208-585-59, 24208-585-64 |
What to do — step by step
Check Your Bottle
Verify if your Cyclopentolate Hydrochloride Ophthalmic Solution matches the recalled NDC numbers and lot numbers listed in the record.
Consult Your Doctor
Contact your healthcare provider to discuss whether you should continue using the product or if a replacement is needed due to the labeling issue.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which specific lot numbers are recalled?
Recalled lots include 199691, 221481, 223921, 226211, 228611, 230711, 232591, 234551, 238871, 239801, 240951, 242801, and 246551 for 2 mL bottles, and 199011, 199692, 221482, 222601, 223922, 226212, 228612, 230712, 232592, 234552, 238872, 239802, 240952, 242802, and 246552 for 15 mL bottles.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0645-2016 (January 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0645-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.