CLASS III Drug recall · Reported 3 Feb 2016 · FDA Enforcement Report
Tropicamide Ophthalmic Solution recalled by Bausch & Lomb
Bausch & Lomb is recalling Tropicamide Ophthalmic Solution USP, 1%, distributed nationwide in the US. The recall was initiated on 18 Jan 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0647-2016
- FDA event ID
- 73032
- Recalling firm
- Bausch & Lomb, Tampa, FL
- Brand
- Tropicamide
- Manufacturer
- Bausch & Lomb Incorporated
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jan 2016
- FDA classified
- 28 Jan 2016
- Reported
- 3 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Eye Drops
Timeline
| 18 Jan 2016 | Recall initiated by company | |
| 28 Jan 2016 | Classified by FDA | +10 days |
| 3 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide including Puerto Rico.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Which lots are affected?
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.
Where was it sold?
U.S. Nationwide including Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 73032This product is part of a recall event; the main page for the event is Cyclopentolate Hydrochloride Ophthalmic Solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Cyclopentolate Hydrochloride Ophthalmic Solution recalledCyclopentolate Hydrochloride | Bausch & Lomb | Packaging Defects | Nationwide | |
| CLASS III | Tropicamide Ophthalmic Solution recalled by Bausch & LombTropicamide | Bausch & Lomb | Packaging Defects | Nationwide |
More recalls from Bausch & Lomb
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalledLotemax | Bausch & Lomb | Potency & Assay | Nationwide |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vit Cutter recalled | Bausch & Lomb | Packaging Defects | 26 states |
Other Tropicamide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled | Fagron Compounding Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL) recalled | Fagron Compounding Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tropicamide Ophthalmic Solution recalled by Mckesson Medical-Surgical | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |